SPADA Docs

Smith (personal communications) in September 2005 and shared with Manufacturer A on 19 216 May 2016. 217

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Orthogonal Testing

Manufacturer A used whole genome sequencing along with Biolog and Vitek 2 GN 219 phenotypic assays to compare F. tularensis test culture lot 2425-3243 with index culture lot 220 9210-2349. These results, which are reported in the attached Certificate of Analysis (1) and 221 detailed on the manufacturer’s website (2), identified 5 single nucleotide polymorphisms in 222 noncoding regions of the bacterial genomes and generated identical genus and species calls on 223 the Biolog and Vitek 2 GN assays. Based on these results, we conclude that the test and index 224 cultures are sufficiently related for the test culture to be used as a surrogate for the index culture 225 in the sponsored study. 226 The manufacturer’s Certificate of Analysis (1) reports that the test and index lots exhibit 228 identical responses to a proprietary fluorescent tagged monoclonal antibody that similarly targets 229 the O-antigen used in the current study’s lateral flow assay. 230 231 (1) Certificate of Analysis for F. tularensis Lot 2425-3243, 9 SEP 2018, Manufacturer A, 232 Boston, MA. 233 (2) Supporting Data, Manufacturer A, http://ManA.com/24253243/SNP.html References Application-Oriented Testing 227

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